Chinese Smartphone App for 6-18 Years With T1DM - RCT

Type1 Diabetes Mellitus Clinical Trial

Official title:

The Impact of a Locally Tailored Evidence-based Chinese Smartphone Application in Management of Type 1 Diabetes Mellitus Aged 6-18 Years in Hong Kong - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05418569
• Other study ID #: PR-HKCH-13
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: June 2022
• Source: Chinese University of Hong Kong
• Contact: Samathan Lee
• Phone: +852 5741 3307
• Email: llk051a[@]ha.org.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Moving into the era of electronic communication, it changes the way we shall engage our children and adolescents. According to data of the Census and Statistics Department of Hong Kong releases in 2019, more than 80% and up to 99.4% of those aged 10-14 years, and aged 15-24 years respectively had a mobile phone device. A recent survey carried by Kebede et al. (2019) had shown that using diabetes apps was positively associated with self-care behavior in type 1 and type 2 diabetes mellitus (DM). A systematic review carried in Spain by Quevedo Rodríguez et al. (2018) had found most of the available smartphone apps lacked quality certification and very few provide scientific references on their content.

In Hong Kong, there is currently no Chinese smartphone application targeting for the pediatric type 1 population, therefore, most of the education is based on face-to-face or telephone communication with the diabetic nurse and endocrinologists in limited encounters. For families or patients with limited command of English language, apart from one adult oriented DM information smartphone application, the chance of having on-hand mobile device support is truly limited. In light of this context, we shall first design an evidence-based locally tailored Chinese smartphone application for pediatric type 1 DM and then evaluate its effectiveness in improving management of type 1 DM in a robust manner.

The main research question for this project is whether a self-help smartphone application in local Chinese language, tailored to include local clinical practice, culture and food spectrum, can improve diabetes control and psychological wellbeing in patients with type 1 diabetes mellitus aged 6-18 years. Eligible participants will be randomized to either using the smartphone application (on top of standard diabetic care) or continue standard diabetic care. The study aims to compare the difference between the two groups for their diabetic control and the psychological wellbeing.

Description:

Objectives To evaluate the impact of a locally designed evidence-based Chinese smartphone application in improving type 1 diabetes mellitus management for aged 6-18 years in Hong Kong.

Hypothesis Use of smartphone application can improve diabetes mellitus control and self-care ability, psychological wellbeing and quality of life.

Design and subjects A single-blinded randomized controlled trial employing block randomization. Inclusion criteria: (1) Type 1 diabetes mellitus diagnosed for at least 6 months, (2) Aged 6-18 years, (3) HbA1c >/=6.0%, (4) Receiving DM care in Hong Kong. Exclusion criteria: (1) Lack of the ability to use a smartphone application, (2) Moderate to severe visual impairment, (3) Cannot read Chinese language. Aim for 57 participants in each of the control and intervention arms for a statistical power of 80%.

Study instruments

(1) HemoglobinA1c, (2) Time in range and frequency of hypoglycaemia by continuous glucose monitoring, (3) Chinese versions of PSC-35, PedsQL and DSMQ questionnaires.

Interventions Use of the smartphone application for 6 months.

Main outcome measures Primary outcomes include (1) HbA1c, (2) Time in range, (2) Frequency of hypoglycaemia. Secondary outcomes are scores of PSC-35, PedsQL and DSMQ.

Data analysis and expected results Data to be analysed with intention-to-treat. A post hoc analysis is planned to capture data in the reduced application usage group. Generalized estimating equation will be employed to analyse the data involving within-subject covariance. Around 10% dropout rate assumed. A statistically significant result is defined by a 2-tailed alpha level of 0.05.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Known type 1 DM diagnosed for at least 6 months

2. Aged 6-18 years

3. HbA1c >/= 6.0% in the preceding 6 months prior to recruitment

4. Receiving DM care in Hong Kong

Exclusion Criteria:

1. Lack of the ability to use a smartphone application despite an introduction session the smartphone application intended for this study

2. Moderate to severe visual impairment that may affect the smartphone application usage

3. Cannot read Chinese language.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Device:
• Intervention arm - A new smartphone application for pediatric type 1 DM
An evidence-based locally tailored Chinese smartphone application for pediatric type 1 DM

Other:
• Standard diabetic eduction
Received standard diabetic care (diabetic nurse education and regular follow-ups) with optional use of an existing smartphone application for general diabetic

Locations

Country	Name	City	State
Hong Kong	Hong Kong Children's Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	A decrease of 0.5% is considered significant	6 months (Assessed at 3 months and 6 months from start of intervention)
Primary	CGM data	Time in range, glycemic variability and percentage of hypoglycemia as documented by continuous glucose monitoring (for a period of 2 weeks) at baseline and at the end of study.	6 months
Primary	Self/Parent-reported questionnaires on hypoglycemia frequency	Self/Parent-reported questionnaires on hypoglycemia frequency, the lowest glucose reading during hypoglycemia and number of severe hypoglycemia requiring glucagon use - to be performed at baseline and at the end of study.	6 months
Secondary	The PSC-35 (Pediatric Symptom Checklist-35 items) questionnaires	The PSC-35 (Pediatric Symptom Checklist-35 items) questionnaires is employed to assess the psychological wellbeing at baseline and at the end of study.	6 months
Secondary	The Chinese version of the Diabetes Self-Management Questionnaire (DSMQ)	The Chinese version of the Diabetes Self-Management Questionnaire (DSMQ) is employed to assess the diabetes self-management behavior at baseline and at the end of study. The data on the questionnaire's use in youths or children are not available yet. We will interpret with caution for those questions not entirely applicable to participants <18 years.	6 months
Secondary	The Chinese version of the Pediatric Quality of Life Inventory 4.0 plus the 3.0 diabetes module	The Chinese version of the Pediatric Quality of Life Inventory 4.0 plus the 3.0 diabetes module to be filled in at baseline and at the end of study.Diabetes module will not be required for participants with ages 5-7 years as Chinese version is currently not available.	6 months
Secondary	Self/Parent-reported questionnaires to assess on carbohydrate counting accuracy on local Hong Kong diet at baseline and at the end of study	Self/Parent-reported questionnaires to assess on carbohydrate counting accuracy on local Hong Kong diet at baseline and at the end of study	6 months
Secondary	Self-reported smartphone application usage satisfaction	Self-reported smartphone application usage satisfaction to be filled at 3 months and the end of study.	6 months